Tissue Drug Levels of HIV Medications

University of Minnesota (UMN)

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Drug: Initiation of anti-retroviral therapy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01490346

P01AI074340 (U.S. NIH Grant/Contract)

0712M22448

Details and patient eligibility

About

The aim of this study is to find out why HIV continues to make copies in people taking HIV drugs. The investigators want to know if the medications most people use to treat HIV get into the lymphatic tissue where HIV persists.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV+
• Treatment naive or >30 days off ARV therapy
• Documented sensitivity to prescribed antiretrovirals
• Age ≥ 18 years
• Negative pregnancy test for eligible women of childbearing potential
• Ready to start ARV therapy

Exclusion criteria

• Contraindications to surgical & endoscopy procedures (as judged by PI)
• Psychiatric or psychological illness that would make adherence to protocol procedures unlikely
• Pregnancy

Trial design

22 participants in 1 patient group

ART treated individuals

Treatment:

Drug: Initiation of anti-retroviral therapy